Therapeutic Progressive Exercise on Shoulder Impingement Syndrome

Tendinopathy Clinical Trial

Official title:

An Innovative Therapeutic Exercise Approach Based on Load Progression Criteria for the Management of Shoulder Impingement Syndrome: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04690049
• Other study ID #: ProgEx-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2025
• Est. completion date: February 2026

Study information

• Verified date: September 2023
• Source: University of Malaga
• Contact: Antonio Cuesta-Vargas, PhD
• Phone: +34951952852
• Email: acuesta[@]uma.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Upper limb tendinopathies, especially the so called "shoulder impingement syndrome", is a common injury among the population. Its management usually involves active treatments, being the therapeutic progressive exercise the most important and effective modality. However, whether a certain criterion is more appropriate than another when progressing the exercise program remains unclear. We propose a new program based on progressive exercises serving as a standard approach for the management of shoulder impingement syndrome.

Description:

Shoulder pain is a common condition affecting our society. It is estimated that between 7 and 67% of the adult population will suffer from shoulder pain at least once in their lifetime. Some research suggest that shoulder impingement syndrome (SIS) is responsible for 44 to 60% from the medical consultations regarding shoulder pain with an approximate prevalence of 70-200 per 1000 adults, which implies a remarkable use of health care resources.

Among all the musculoskeletal injuries affecting the shoulder complex, SIS remains as the most common condition, characterized for leading to loss function and disability. Its pathogenesis is associated with the affection of diverse structures and tissues like the subacromial bursa, rotator cuff tendons, acromion, coracoacromial ligament and the long head of biceps brachii. The etiology of this condition comprises multiple causes, including capsular tightness, alteration of shoulder kinematics with scapula dysfunction and muscle imbalance, and also the overuse factor.

Treatment modalities to deal with SIS embrace both surgical procedures, i.e., arthroscopic subacromial decompression) and conservative approaches (i.e., physical therapy), becoming the therapeutic exercise increasingly popular due to arising evidence from the last 30 years. Furthermore, with regard to potential effects, therapeutic exercise presents itself as a safer and less aggressive alternative, causing fewer adverse effects than pharmacological or surgical options, which are relegated preferably as secondary choices.

There is a wide evidence supporting the exercise therapy as an effective strategy for the management of SIS. However, some controversy exists regarding the optimal approach in terms of intensity, frequency and number of repetitions. Thus, a program acting as a gold standard for the development and progression of the proposed exercises is still lacking, especially when attempting to estimate the pure effect of progressive exercise in isolation between experimental and control group.

Prior research evaluating the effect of progressive exercise for the management of SIS usually included programs with a duration of 3 months. However, other studies established follow-up periods of either one month and a half or, conversely, more than 6 months. That, together with the wide variety of post-treatment follow-ups, makes it difficult to find the optimal period where the results derived inherently from the intervention and not from the natural course of the condition may be observed.

Regarding the progression criteria, there seems to be a tendency to consider the modulation of the painful sensation as the main benchmark from which the exercise may progress in difficulty, but some other progression sub-criteria can also be found, such as fatigue or subjective perception. Furthermore, the presence of other conditioning elements, like proximity to pain threshold or a certain reference value in the Visual Analogue Scale (VAS), reduces the homogeneity among the exercise programs and hinders the standardization of the ideal exercise progression when performing the exercises for the management of SIS.

The main objective of this clinical trial is to prove the efficacy of a progressive exercise program based on strength and resistance training in comparison to an exercise protocol from the literature to increase neuromuscular and cardiorespiratory capacities and improve the symptoms in subjects with SIS. In addition, we propose to determine the existence or not of statistically significant differences between treatment modalities by evaluating whether these changes occur before, during or after the application of the proposed exercise protocol.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects older than 18 years.

• Subjects previously diagnosed with shoulder impingement syndrome.

• Presence of 3 of the following sings: impingement sign according to Neer and to Hawking-Kennedy, positive result on Jobes test, painful arc, and positive result on Patte's manoeuvre.

Exclusion Criteria:

• Findings of spinal radiculopathy.

• General neck and shoulder pain.

• Symptoms of frozen shoulder.

• Pregnancy.

• Fybromyalgia.

• Suspected polyarthritis.

• Chronic pain syndrome.

• Altered blood coagulation.

• Consumption of anticoagulants, opioids or antiepileptics.

• Drug intakes.

• Alcohol intakes higher than 27.4 grams for men or 13.7 grams for women.

• Allergies.

• Cancer.

Related Conditions & MeSH terms

• Shoulder Impingement
• Shoulder Impingement Syndrome
• Tendinopathy

Intervention

Other:
• Neuromuscular resistance exercise program
This neuromuscular resistance exercise program will be organized in 5 stages, distributing the different phases in 2, 4, 4, 2 and 2 weeks respectively, with a frequency of 3 sessions/week. In addition, 2 weekly sessions of aerobic work with cycloergometer will be developed. The duration of each session will last 30 minutes. The parameters of load and execution speed will be modified as the exercise program progresses along the phases, with the goal of have an impact on the different aspects of the neuromuscular system.
• Control exercise program with elastic band
This program is based on previous literature so that it remains comparable to the experimental program. The parameters will consist in 3 sets of 10 repetitions, 2 times/day, 3 times/week, for a total of 6 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

References & Publications (15)

Brox JI, Gjengedal E, Uppheim G, Bohmer AS, Brevik JI, Ljunggren AE, Staff PH. Arthroscopic surgery versus supervised exercises in patients with rotator cuff disease (stage II impingement syndrome): a prospective, randomized, controlled study in 125 patients with a 2 1/2-year follow-up. J Shoulder Elbow Surg. 1999 Mar-Apr;8(2):102-11. doi: 10.1016/s1058-2746(99)90001-0. — View Citation

Cardoso TB, Pizzari T, Kinsella R, Hope D, Cook JL. Current trends in tendinopathy management. Best Pract Res Clin Rheumatol. 2019 Feb;33(1):122-140. doi: 10.1016/j.berh.2019.02.001. Epub 2019 Mar 8. — View Citation

Cook JL. Ten treatments to avoid in patients with lower limb tendon pain. Br J Sports Med. 2018 Jul;52(14):882. doi: 10.1136/bjsports-2018-099045. Epub 2018 Feb 23. No abstract available. — View Citation

Hallgren HC, Holmgren T, Oberg B, Johansson K, Adolfsson LE. A specific exercise strategy reduced the need for surgery in subacromial pain patients. Br J Sports Med. 2014 Oct;48(19):1431-6. doi: 10.1136/bjsports-2013-093233. Epub 2014 Jun 26. — View Citation

Heron SR, Woby SR, Thompson DP. Comparison of three types of exercise in the treatment of rotator cuff tendinopathy/shoulder impingement syndrome: A randomized controlled trial. Physiotherapy. 2017 Jun;103(2):167-173. doi: 10.1016/j.physio.2016.09.001. Epub 2016 Sep 21. — View Citation

Holmgren T, Oberg B, Sjoberg I, Johansson K. Supervised strengthening exercises versus home-based movement exercises after arthroscopic acromioplasty: a randomized clinical trial. J Rehabil Med. 2012 Jan;44(1):12-8. doi: 10.2340/16501977-0889. — View Citation

Ketola S, Lehtinen JT, Arnala I. Arthroscopic decompression not recommended in the treatment of rotator cuff tendinopathy: a final review of a randomised controlled trial at a minimum follow-up of ten years. Bone Joint J. 2017 Jun;99-B(6):799-805. doi: 10.1302/0301-620X.99B6.BJJ-2016-0569.R1. — View Citation

Kuhn JE. Exercise in the treatment of rotator cuff impingement: a systematic review and a synthesized evidence-based rehabilitation protocol. J Shoulder Elbow Surg. 2009 Jan-Feb;18(1):138-60. doi: 10.1016/j.jse.2008.06.004. Epub 2008 Oct 2. — View Citation

Ludewig PM, Cook TM. Alterations in shoulder kinematics and associated muscle activity in people with symptoms of shoulder impingement. Phys Ther. 2000 Mar;80(3):276-91. — View Citation

Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667. — View Citation

Marin-Gomez M, Navarro-Collado MJ, Peiro S, Trenor-Gomis C, Paya-Rubio A, Bernal-Delgado E, Hernandez-Royo A. [The quality of care in shoulder pain. A medical audit]. Gac Sanit. 2006 Mar-Apr;20(2):116-23. doi: 10.1157/13087322. Spanish. — View Citation

Miranda H, Viikari-Juntura E, Martikainen R, Takala EP, Riihimaki H. A prospective study of work related factors and physical exercise as predictors of shoulder pain. Occup Environ Med. 2001 Aug;58(8):528-34. doi: 10.1136/oem.58.8.528. — View Citation

Osteras H, Torstensen TA, Osteras B. High-dosage medical exercise therapy in patients with long-term subacromial shoulder pain: a randomized controlled trial. Physiother Res Int. 2010 Dec;15(4):232-42. doi: 10.1002/pri.468. — View Citation

Seitz AL, McClure PW, Finucane S, Boardman ND 3rd, Michener LA. Mechanisms of rotator cuff tendinopathy: intrinsic, extrinsic, or both? Clin Biomech (Bristol, Avon). 2011 Jan;26(1):1-12. doi: 10.1016/j.clinbiomech.2010.08.001. Epub 2010 Sep 16. — View Citation

Tyler TF, Nicholas SJ, Roy T, Gleim GW. Quantification of posterior capsule tightness and motion loss in patients with shoulder impingement. Am J Sports Med. 2000 Sep-Oct;28(5):668-73. doi: 10.1177/03635465000280050801. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Function measured with Disability of the Arm, Shoulder and Hand (DASH)	Functional scores from Disability of the Arm, Shoulder and Hand (DASH) questionnaire.; Score ranges from 0 (no disability) to 100 (most severe disability)	14 weeks
Primary	Change from baseline in Function measured with Constant-Murley Score (CMS)	Functional scores from Constant-Murley Score (CMS) Constant-Murley score (CMS) is a 100-points scale: the higher the score, the higher the quality of the function.	14 weeks
Primary	Change from baseline in Function measured with Upper Limb Functional Index (ULFI)	Functional scores from Upper Limb Functional Index (ULFI) Score ranges from 0 (no disability) to 25 (most severe disability)	14 weeks
Primary	Change from baseline Painful Sensation	Pain scores from Visual Analogue Scale (VAS) Score ranges from 0 (no pain) to 10 (most severe pain)	14 weeks
Primary	Change from baseline Range of motion (ROM)	Active shoulder joint ROM (flexion, extension, abduction, internal/external rotations) by goniometry	14 weeks
Primary	Change from baseline Subacromial Space	Measurement of subacromial space by ultrasonography	14 weeks
Secondary	Change from baseline Quality of Life	Quality of life scores from EuroQol-5D questionnaire; EQ-5D embodies two components: Health state description: subjects select one of three different levels of problem severity within each of five health domains. The levels are none, moderate and severe/extreme (coded 1 through 3, respectively), whilst the domains are mobility, capacity for self-care, conduct of usual activities, pain/discomfort and anxiety/depression.; Evaluation: using a visual analogue scale (VAS), ranging from 0 ("worst imaginable health state") and at 100 ("best imaginable health state")	14 weeks
Secondary	Change from baseline Health Status	Health status scores from Short-Form 12 (SF-12) questionnaire SF-12 gathers information from eight domains: the higher the scores, the better the health)	14 weeks